BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING SL BALLOON DILATATION CATHETER

    MDR report key: 1984054 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00186
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K093720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A STERLING SL BALLOON CATHETER. IT WAS NOTED DURING UNPACKAGING THAT DRIED BLOOD AND CONTRAST WERE PRESENT ON THE OUTER AND INNER SURFACES OF THE DEVICE. THE DEVICE WAS PREPPED ACCORDING TO THE DFU, AND A NEW INFLATION DEVICE FILLED WITH WATER WAS CONNECTED TO THE INFLATION PORT TO INFLATE THE DEVICE. WHEN POSITIVE PRESSURE WAS APPLIED WITH THE INFLATION DEVICE, A STREAM OF WATER EMITTED FROM A HOLE IN THE BALLOON ON THE DISTAL SIDE OF THE DISTAL MARKERBAND. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING BATCH RECORD REVIEW FOR THE REPORTED BATCH CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE PHYSICIAN ACCESSED THE LEFT FEMORAL ARTERY. THE 90% STENOSED DENOVO LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. THE PHYSICIAN USED A STERLING SL MR 3X120X150 BALLOON FOR PREDILATATION. THE BALLOON WAS INFLATED ONCE TO 6ATMS. THE BALLOON A SECOND TIME TO 6 ATMS AND RUPTURED AFTER BEING INFLATED 30 SECONDS. THE PROCEDURE WAS COMPLETED WITH A STERLING MR 3.0X40MM BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE PHYSICIAN ACCESSED THE LEFT FEMORAL ARTERY. THE 90% STENOSED DENOVO LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFICAFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. THE PHYSICIAN USED A STERLING SL MR 3X120X150 BALLOON FOR PREDILATATION. THE BALLOON WAS INFLATED ONCE TO 6ATMS. THE BALLOON A SECOND TIME TO 6 ATMS AND RUPTURED AFTER BEING INFLATED 30 SECONDS. THE PROCEDURE WAS COMPLETED WITH A STERLING MR 3.0X40MM BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING SL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939147301210 13782948

    Patients

    Seq Age Sex Outcome Treatment
    1 B-BROWN INFLATION DEVICE| 6FR MACH1 ST 55CM GUIDE CATHETER| 6FR BRITE TIP INTRODUCER| SV GUIDE WIRE